To the Editor:

Chronic cutaneous lupus erythematosus (CCLE) is an inflammatory condition with myriad cutaneous manifestations. Most forms of CCLE have the potential to progress to systemic lupus erythematosus (SLE).¹

Blaschkolinear lupus erythematosus (BLE) is an exceedingly rare subtype of cutaneous lupus erythematosus that usually manifests during childhood as linear plaques along the lines of Blaschko.^2,3 Under normal conditions, Blaschko lines are not noticeable; they correspond to the direction of ectodermal cell migration during cutaneous embryogenesis.^4,5 The embryonic cells travel ventrolaterally, forming a V-shaped pattern on the back, an S-shaped pattern on the trunk, and an hourglass-shaped pattern on the face with several perpendicular intersections near the mouth and nose.⁶ During their migration, the cells are susceptible to somatic mutations and clonal expansion, resulting in a monoclonal population of genetically heterogenous cells. This phenomenon is known as somatic mosaicism and may lead to an increased susceptibility to an array of congenital and inflammatory dermatoses, such as cutaneous lupus erythematosus.⁴ Blaschkolinear entities tend to manifest in a unilateral distribution following exposure to a certain environmental trigger, such as trauma, viral illness, or UV radiation, although a trigger is not always present.⁷ We report a case of BLE manifesting on the head and neck in an adult patient.

A 46-year-old man presented with a pruritic rash of 3 months’ duration on the right cheek that extended inferiorly to the right upper chest. He had a medical history of well-controlled psoriasis, and he denied any antecedent trauma, fevers, chills, arthralgia, or night sweats. There had been no improvement with mometasone ointment 0.1% applied daily for 2 months as prescribed by his primary care provider. Physical examination revealed indurated, red-brown, atrophic plaques in a blaschkolinear distribution around the nose, right upper jaw, right side of the neck, and right upper chest (Figure, A).

To the Editor:

Chronic cutaneous lupus erythematosus (CCLE) is an inflammatory condition with myriad cutaneous manifestations. Most forms of CCLE have the potential to progress to systemic lupus erythematosus (SLE).¹

Blaschkolinear lupus erythematosus (BLE) is an exceedingly rare subtype of cutaneous lupus erythematosus that usually manifests during childhood as linear plaques along the lines of Blaschko.^2,3 Under normal conditions, Blaschko lines are not noticeable; they correspond to the direction of ectodermal cell migration during cutaneous embryogenesis.^4,5 The embryonic cells travel ventrolaterally, forming a V-shaped pattern on the back, an S-shaped pattern on the trunk, and an hourglass-shaped pattern on the face with several perpendicular intersections near the mouth and nose.⁶ During their migration, the cells are susceptible to somatic mutations and clonal expansion, resulting in a monoclonal population of genetically heterogenous cells. This phenomenon is known as somatic mosaicism and may lead to an increased susceptibility to an array of congenital and inflammatory dermatoses, such as cutaneous lupus erythematosus.⁴ Blaschkolinear entities tend to manifest in a unilateral distribution following exposure to a certain environmental trigger, such as trauma, viral illness, or UV radiation, although a trigger is not always present.⁷ We report a case of BLE manifesting on the head and neck in an adult patient.

A 46-year-old man presented with a pruritic rash of 3 months’ duration on the right cheek that extended inferiorly to the right upper chest. He had a medical history of well-controlled psoriasis, and he denied any antecedent trauma, fevers, chills, arthralgia, or night sweats. There had been no improvement with mometasone ointment 0.1% applied daily for 2 months as prescribed by his primary care provider. Physical examination revealed indurated, red-brown, atrophic plaques in a blaschkolinear distribution around the nose, right upper jaw, right side of the neck, and right upper chest (Figure, A).

To the Editor:

Chronic cutaneous lupus erythematosus (CCLE) is an inflammatory condition with myriad cutaneous manifestations. Most forms of CCLE have the potential to progress to systemic lupus erythematosus (SLE).¹

Blaschkolinear lupus erythematosus (BLE) is an exceedingly rare subtype of cutaneous lupus erythematosus that usually manifests during childhood as linear plaques along the lines of Blaschko.^2,3 Under normal conditions, Blaschko lines are not noticeable; they correspond to the direction of ectodermal cell migration during cutaneous embryogenesis.^4,5 The embryonic cells travel ventrolaterally, forming a V-shaped pattern on the back, an S-shaped pattern on the trunk, and an hourglass-shaped pattern on the face with several perpendicular intersections near the mouth and nose.⁶ During their migration, the cells are susceptible to somatic mutations and clonal expansion, resulting in a monoclonal population of genetically heterogenous cells. This phenomenon is known as somatic mosaicism and may lead to an increased susceptibility to an array of congenital and inflammatory dermatoses, such as cutaneous lupus erythematosus.⁴ Blaschkolinear entities tend to manifest in a unilateral distribution following exposure to a certain environmental trigger, such as trauma, viral illness, or UV radiation, although a trigger is not always present.⁷ We report a case of BLE manifesting on the head and neck in an adult patient.

A 46-year-old man presented with a pruritic rash of 3 months’ duration on the right cheek that extended inferiorly to the right upper chest. He had a medical history of well-controlled psoriasis, and he denied any antecedent trauma, fevers, chills, arthralgia, or night sweats. There had been no improvement with mometasone ointment 0.1% applied daily for 2 months as prescribed by his primary care provider. Physical examination revealed indurated, red-brown, atrophic plaques in a blaschkolinear distribution around the nose, right upper jaw, right side of the neck, and right upper chest (Figure, A).

TOPLINE:

The COVID-19 booster was linked to shorter menstrual cycles in adolescent girls in the 4 months following administration, particularly when teens were in their follicular phase. The vaccine did not appear to be associated with shifts in menstrual flow, pain, or other symptoms.
 

METHODOLOGY:

• Reports of menstrual cycle changes following the COVID-19 vaccination began to emerge in early 2021, raising concerns about the impact of the vaccine on menstrual health.
• Researchers conducted a prospective study including 65 adolescent girls (mean age, 17.3 years), of whom 47 had received an initial series of COVID-19 vaccination at least 6 months prior to receiving a booster dose (booster group), and 18 had not received the booster vaccine (control group), two of whom had never received any COVID-19 vaccine, four who had received an initial vaccine but not a booster, and 12 who had received an initial vaccine and booster but more than 6 months prior to the study.
• Menstrual cycle length was measured for three cycles prior to and four cycles after vaccination in the booster group and for seven cycles in the control group.
• Menstrual flow, pain, and stress were measured at baseline and monthly for 3 months post vaccination.

TAKEAWAY:

• Participants in the booster group experienced shorter cycles by an average of 5.35 days after receiving the COVID-19 booster vaccine (P = .03), particularly during the second cycle. In contrast, those in the control group did not experience any changes in the menstrual cycle length.
• Receiving the booster dose in the follicular phase was associated with significantly shorter menstrual cycles, compared with pre-booster cycles (P = .0157).
• Menstrual flow, pain, and other symptoms remained unaffected after the COVID-19 booster vaccination.
• Higher stress levels at baseline were also associated with a shorter length of the menstrual cycle (P = .03) in both groups, regardless of the booster vaccination status.

IN PRACTICE:

“These data are potentially important for counseling parents regarding potential vaccine refusal in the future for their teen daughters,” the authors wrote.

SOURCE:

This study was led by Laura A. Payne, PhD, from McLean Hospital in Boston, and was published online in the Journal of Adolescent Health.

LIMITATIONS:

The sample size for the booster and control groups was relatively small and homogeneous. The study did not include the height, weight, birth control use, or other chronic conditions of the participants, which may have influenced the functioning of the menstrual cycle. The control group included a majority of teens who had previously received a vaccine and even a booster, which could have affected results.

DISCLOSURES:

This study was supported by grants from the Eunice Kennedy Shriver National Institute for Child Health and Human Development. Some authors received consulting fees, travel reimbursements, honoraria, research funding, and royalties from Bayer Healthcare, Mahana Therapeutics, Gates, and Merck, among others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The COVID-19 booster was linked to shorter menstrual cycles in adolescent girls in the 4 months following administration, particularly when teens were in their follicular phase. The vaccine did not appear to be associated with shifts in menstrual flow, pain, or other symptoms.
 

METHODOLOGY:

• Reports of menstrual cycle changes following the COVID-19 vaccination began to emerge in early 2021, raising concerns about the impact of the vaccine on menstrual health.
• Researchers conducted a prospective study including 65 adolescent girls (mean age, 17.3 years), of whom 47 had received an initial series of COVID-19 vaccination at least 6 months prior to receiving a booster dose (booster group), and 18 had not received the booster vaccine (control group), two of whom had never received any COVID-19 vaccine, four who had received an initial vaccine but not a booster, and 12 who had received an initial vaccine and booster but more than 6 months prior to the study.
• Menstrual cycle length was measured for three cycles prior to and four cycles after vaccination in the booster group and for seven cycles in the control group.
• Menstrual flow, pain, and stress were measured at baseline and monthly for 3 months post vaccination.

TAKEAWAY:

• Participants in the booster group experienced shorter cycles by an average of 5.35 days after receiving the COVID-19 booster vaccine (P = .03), particularly during the second cycle. In contrast, those in the control group did not experience any changes in the menstrual cycle length.
• Receiving the booster dose in the follicular phase was associated with significantly shorter menstrual cycles, compared with pre-booster cycles (P = .0157).
• Menstrual flow, pain, and other symptoms remained unaffected after the COVID-19 booster vaccination.
• Higher stress levels at baseline were also associated with a shorter length of the menstrual cycle (P = .03) in both groups, regardless of the booster vaccination status.

IN PRACTICE:

“These data are potentially important for counseling parents regarding potential vaccine refusal in the future for their teen daughters,” the authors wrote.

SOURCE:

This study was led by Laura A. Payne, PhD, from McLean Hospital in Boston, and was published online in the Journal of Adolescent Health.

LIMITATIONS:

The sample size for the booster and control groups was relatively small and homogeneous. The study did not include the height, weight, birth control use, or other chronic conditions of the participants, which may have influenced the functioning of the menstrual cycle. The control group included a majority of teens who had previously received a vaccine and even a booster, which could have affected results.

DISCLOSURES:

This study was supported by grants from the Eunice Kennedy Shriver National Institute for Child Health and Human Development. Some authors received consulting fees, travel reimbursements, honoraria, research funding, and royalties from Bayer Healthcare, Mahana Therapeutics, Gates, and Merck, among others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The COVID-19 booster was linked to shorter menstrual cycles in adolescent girls in the 4 months following administration, particularly when teens were in their follicular phase. The vaccine did not appear to be associated with shifts in menstrual flow, pain, or other symptoms.
 

METHODOLOGY:

• Reports of menstrual cycle changes following the COVID-19 vaccination began to emerge in early 2021, raising concerns about the impact of the vaccine on menstrual health.
• Researchers conducted a prospective study including 65 adolescent girls (mean age, 17.3 years), of whom 47 had received an initial series of COVID-19 vaccination at least 6 months prior to receiving a booster dose (booster group), and 18 had not received the booster vaccine (control group), two of whom had never received any COVID-19 vaccine, four who had received an initial vaccine but not a booster, and 12 who had received an initial vaccine and booster but more than 6 months prior to the study.
• Menstrual cycle length was measured for three cycles prior to and four cycles after vaccination in the booster group and for seven cycles in the control group.
• Menstrual flow, pain, and stress were measured at baseline and monthly for 3 months post vaccination.

TAKEAWAY:

• Participants in the booster group experienced shorter cycles by an average of 5.35 days after receiving the COVID-19 booster vaccine (P = .03), particularly during the second cycle. In contrast, those in the control group did not experience any changes in the menstrual cycle length.
• Receiving the booster dose in the follicular phase was associated with significantly shorter menstrual cycles, compared with pre-booster cycles (P = .0157).
• Menstrual flow, pain, and other symptoms remained unaffected after the COVID-19 booster vaccination.
• Higher stress levels at baseline were also associated with a shorter length of the menstrual cycle (P = .03) in both groups, regardless of the booster vaccination status.

IN PRACTICE:

“These data are potentially important for counseling parents regarding potential vaccine refusal in the future for their teen daughters,” the authors wrote.

SOURCE:

This study was led by Laura A. Payne, PhD, from McLean Hospital in Boston, and was published online in the Journal of Adolescent Health.

LIMITATIONS:

The sample size for the booster and control groups was relatively small and homogeneous. The study did not include the height, weight, birth control use, or other chronic conditions of the participants, which may have influenced the functioning of the menstrual cycle. The control group included a majority of teens who had previously received a vaccine and even a booster, which could have affected results.

DISCLOSURES:

This study was supported by grants from the Eunice Kennedy Shriver National Institute for Child Health and Human Development. Some authors received consulting fees, travel reimbursements, honoraria, research funding, and royalties from Bayer Healthcare, Mahana Therapeutics, Gates, and Merck, among others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

A version of this article first appeared on Medscape.com.

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

A version of this article first appeared on Medscape.com.

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

A version of this article first appeared on Medscape.com.

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.

But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
 

Beyond One-Size-Fits-All

The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.

In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.

“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.

Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.

They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.

“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.

“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.

Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
 

Precision Tools

A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.

Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.

MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.

“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.

Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.

“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.

Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
 

The Future Is Already Here

The implementation and widespread adoption of precision psychiatry have several challenges.

It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.

Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.

Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.

Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.

“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.

“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.

Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.

“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.

Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.

Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
 

A version of this article first appeared on Medscape.com.

The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.

But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
 

Beyond One-Size-Fits-All

The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.

In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.

“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.

Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.

They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.

“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.

“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.

Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
 

Precision Tools

A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.

Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.

MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.

“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.

Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.

“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.

Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
 

The Future Is Already Here

The implementation and widespread adoption of precision psychiatry have several challenges.

It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.

Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.

Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.

Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.

“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.

“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.

Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.

“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.

Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.

Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
 

A version of this article first appeared on Medscape.com.

The field of psychiatry is experiencing a transformative shift toward precision medicine, a paradigm that tailors treatment to the unique characteristics of individual patients. This approach echoes advances in fields like oncology and cardiology, where precision tools have already revolutionized patient care.

But what exactly is precision psychiatry? How does it differ from traditional psychiatry? What will it look like in clinical practice? And are we there yet?
 

Beyond One-Size-Fits-All

The prevailing “one-size-fits-all” approach in psychiatry, which relies heavily on subjective symptom reporting, often proves ineffective due to the broad heterogeneity of diagnostic categories. This can lead to a “trial-and-error” cycle in treatment, which is time-consuming, costly, and frustrating for both doctors and patients.

In contrast, precision psychiatry has the potential to identify subtypes of psychiatric disorders and tailor treatments using measurable, objective data.

“The data supporting the use of precision psychiatry are very promising, particularly for treatment-resistant depression,” Leanne Williams, PhD, professor in the Department of Psychiatry and Behavioral Sciences at Stanford University, Stanford, and director of the Stanford Center for Precision Mental Health and Wellness, Palo Alto, California, said in an interview with this news organization.

Using functional MRI (fMRI), Dr. Williams and her team have mapped and measured patients’ brain circuitry to identify eight “biotypes” of depression that reflect combinations of dysfunction in six different circuits of the brain.

They are using these biotypes to guide treatment decisions in the clinic, matching individual patients to more targeted and effective therapies.

“We’re offering functional MRI to directly assess brain function along with other measures, so precision psychiatry is happening, and it’s really wanted by patients and their families. And the data suggest that we can double the rate of good outcomes,” said Dr. Williams.

“Neuroimaging techniques, particularly fMRI, have revolutionized our ability to map and quantify circuit abnormalities. Neural circuit measurements potentially offer the most direct window into the neural bases of psychiatric symptoms and, crucially, their modulation by treatment,” Teddy Akiki, MD, clinical scholar, Department of Psychiatry and Behavioral Sciences at Stanford, California, who works with Dr. Williams, told this news organization.

Blood-based biomarkers can complement brain imaging by providing additional information to better target treatment, help predict side effects, and guide dosage adjustments.
 

Precision Tools

A team led by Alexander B. Niculescu, III, MD, PhD, has found that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices.

Dr. Niculescu is currently a professor of psychiatry and medical neuroscience at the Indiana University School of Medicine, Indianapolis. He will head west in September to direct the newly created Center for Precision Psychiatry at the University of Arizona College of Medicine–Phoenix.

MindX Sciences, the start-up company Dr. Niculescu cofounded, has been providing blood biomarker reports to “early adopting” doctors and patients.

“We are in the process of collecting and writing up the outcome data on the first 100 cases. The feedback we have received so far from the doctors and patients who have used it, as well as biopharma companies who have used it, has been very positive,” Dr. Niculescu told this news organization.

Another benefit of precision psychiatry lies in its potential to significantly accelerate drug development.

“By identifying specific neural circuits involved in subtypes of psychiatric conditions, we can repurpose or develop drugs that target these circuits more precisely. This approach allows for smaller, more focused trials with potentially higher success rates, which could speed up the typically slow and costly process of psychiatric drug development,” said Dr. Akiki.

Dr. Niculescu agreed. With precision psychiatry tools, “psychiatric drug development will become faster, cheaper, and more successful with the use of biomarkers and other precision tools,” he said.
 

The Future Is Already Here

The implementation and widespread adoption of precision psychiatry have several challenges.

It requires sophisticated technology and expertise, which may not be readily available in all clinical settings. Moreover, while evidence supports its use in conditions like major depression, there are fewer data on its efficacy in other psychiatric disorders, like schizophrenia.

Dr. Williams said future research should focus on expanding the evidence base for precision psychiatry across a broader range of psychiatric conditions.

Efforts to make precision tools more accessible and scalable, such as developing portable imaging technologies or more readily available biomarker tests, are also critical.

Integrating these precision tools into routine psychiatric practice will also require training and education for clinicians, as well as cost-effective solutions to make these approaches widely available.

“Mental health clinicians throughout the country are starting to employ semi-objective and objective measures in their practices, particularly self-report symptom questionnaires and pharmacogenomic assessment,” Laura Hack, MD, PhD, assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University, told this news organization.

“For precision psychiatry measures to be widely implemented, it is essential to demonstrate their reliability, clinical validity, clinical utility, and cost-effectiveness. Additionally, there is a need to develop clinical guidelines for their use, ensure that measurement tools are accessible, and educate all relevant stakeholders,” said Dr. Hack.

Right now, functional neuroimaging is used “only on a very limited basis in current clinical psychiatric practice,” Dr. Hack noted.

“We are developing standardized systems that will require less specialized expertise in functional neuroimaging and can be readily integrated into routine clinical care,” Dr. Akiki added.

Quoting William Gibson, “The future [of precision psychiatry] is already here; it’s just not evenly distributed,” said Dr. Niculescu.

Dr. Williams has disclosed relationships with One Mind PsyberGuide, Laureate Institute for Brain Research, and Et Cere Inc. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University. Dr. Akiki and Dr. Hack had no relevant disclosures.
 

A version of this article first appeared on Medscape.com.

Advocacy groups for patients with neurologic disorders have become a common feature in the landscape of drug and device development and federal research funding allocation.

On Capitol Hill, advocates have racked up some impressive legislative wins that aim to set a federal agenda for developing new medications.

At the Food and Drug Administration (FDA), advocacy groups played a significant role in several recent high-profile and controversial approvals for drugs for Alzheimer’s disease, Duchenne muscular dystrophy (DMD), and amyotrophic lateral sclerosis (ALS).

Such gains suggest these groups are growing in power. But with these wins come questions about whether large advocacy organizations — some of which receive significant industry funding — wield too much influence.

“You need to think very carefully about how you open these processes up to greater patient involvement,” Matthew S. McCoy, PhD, assistant professor of medical ethics and health policy at the University of Pennsylvania, Philadelphia, told this news organization. It’s important not to “end up with a situation where it’s the best-connected, the most well-resourced, the most-savvy patient organizations that are able to exercise outsize influence.”

Just because a group has deep pockets does not mean that its priorities align with the disease burden. And not every patient population is represented by a professionalized patient advocacy organization, Dr. McCoy noted. “There is the potential for the rich to get richer.”
 

A Seat at the Table

Long ago, the FDA and the National Institutes of Health (NIH) began giving patients a seat at the table, in part because of the path blazed by AIDS activists in the late 1980s and early 1990s, said Dr. McCoy.

Patient advocacy is often visible during FDA advisory committee meetings. The agency usually allows an hour, sometimes more, for members of the public to express support or concerns about the product being reviewed. Patients and caregivers — often aided by advocacy organizations — also submit hundreds, sometimes thousands, of letters before a product review.

The Alzheimer’s Association spent years advocating for approval of the anti-amyloid agent aducanumab (Aduhelm, Biogen/Eisai). In 2020, the organization urged patients and caregivers to submit written and oral testimony to the FDA advisory panel that was reviewing the drug. Despite patients’ pleas, the panel ultimately declined to support the drug’s approval, citing safety concerns and limited evidence of efficacy.

As controversy swirled around the medication — which had the potential for life-threatening brain swelling — advocates continued to apply pressure. Going against the expert panel’s recommendation, in June 2021, the FDA granted accelerated approval prompting three of the panelists to resign in protest.

Aducanumab’s initial price — $56,000 a year — was seen as a major threat to the viability of Medicare. Still, the Alzheimer’s Association stood behind the decision to approve the drug. But by early 2024, Biogen/Eisai said they would stop selling aducanumab, citing other priorities.

Once again patient advocates showed up in March 2022 when the FDA advisers were reviewing Amylyx Pharmaceuticals’ ALS drug Relyvrio (sodium phenylbutyrate and taurursodiol). Trials had showed limited efficacy, but patients testified they would accept greater risk for a chance to be treated with the drug. The committee ultimately voted against approval; 6 months later, the FDA approved Relyvrio anyway.

In April 2024, Amylyx removed Relyvrio from the market following phase 3 trial results that showed no difference between the treatment and placebo.

The drug manufacturer Sarepta Therapeutics, which develops treatments for genetic conditions such as DMD, has a history of working with — and funding — patient advocacy groups. The company encourages nonprofits to apply for grants or sponsorship on its website. At a 2016 advisory committee, when Sarepta was seeking approval of its first DMD therapy eteplirsen (Exondys 51), 52 speakers, most from patient advocacy groups, pleaded for the drug’s approval. When the panel voted no, Sarepta mobilized families to pressure the agency. Exondys was eventually approved.

In June, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, unilaterally gave final expanded approval to Sarepta Therapeutics’ gene therapy Elevidys for DMD. Dr. Marks overrode his own FDA reviewers, who said the product lacked substantial evidence of efficacy. He acknowledged the drug had not met its primary endpoint but said he found secondary and exploratory endpoints “compelling” and cited an unmet medical need.

In an opinion piece in The Washington Post, Aaron Kesselheim, MD, JD, MPH, the director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, Boston, Massachusetts, and a former member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, questioned the approval stating that it undermined both public trust and manufacturers’ incentives to do the hard work of proving effectiveness.
 

Patient Voices the ‘Secret Sauce’

Drugmakers aren’t alone in seeing the value of having patients speak directly to government entities. When the Michael J. Fox Foundation wanted to gather cosponsors for the National Plan to End Parkinson’s Act, which President Joe Biden signed into law in July, it recruited and trained patients and caregivers for congressional meetings, said Ted Thompson, senior vice president of public policy at the foundation.

Having those individuals “making the personal case for how this disease affects their families ... was really the secret sauce,” in garnering a large number of cosponsors and getting legislation signed into law within 2 years of its introduction, Mr. Thompson told this news organization.

ALS advocacy groups launched a similar campaign to secure passage of the Accelerating Access to Critical Therapies for ALS Act in 2021.

Both pieces of legislation seek to set a federal agenda for developing new therapies in neurodegenerative diseases, in part by directing the FDA and NIH to fund research, engage patients more directly, and form public-private partnerships and councils to spur innovation.

But some said patient advocates are still coming far too late to the party.

“By the time you hear from patient groups at the meetings at the FDA, often the best opportunities for their input are long past,” Leah Zoe Gibson Rand, DPhil, a research scientist with the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, told this news organization. There should be more focus on the patient perspective earlier in drug development and trial design.

“There are some things that the patient voice could uniquely tell the agency,” said Holly Fernandez Lynch, JD, associate professor of medical ethics and health policy at the University of Pennsylvania. Patients can give insight on what it means to live with a disease, what symptoms are particularly burdensome, and which endpoints matter.

But, she said, “listening to the patient voice cannot mean that FDA just steps aside and lets anything on the market that patients are willing to try.” Individuals “who lack good treatment options have a very good reason to want to try things that haven’t yet been proven.”

If the FDA allows drugs on the market just because patients are willing to try, “5 or 10 years down the road, it’s not at all clear that we would end up with drugs that are better, or drugs that work, or drugs that we know anything more about,” said Dr. Lynch.
 

Does Taking Industry Money Equal Conflicts of Interest?

Many patient advocacy organizations receive funding from drug companies, medical device makers, or other industry sources, but they aren’t always transparent about how much or from which companies, according to studies.

The Alzheimer’s Association continued to push for the approval of aducanumab, even as the group received millions of dollars from the drugmakers. The association was accused of failing to disclose the potential conflict. It still lobbied for approval, even after the FDA advisers in 2020 voted against the drug.

It is not uncommon for individuals who speak in favor of a product’s approval to receive money for transportation and/or lodging from the drug’s manufacturer. In 2018, Dr. McCoy and colleagues reported in JAMA Internal Medicine that, between 2009 and 2017, a quarter of the speakers at the Anesthetic and Analgesic Drug Products Advisory Committee had conflicts of interest (COIs), mostly from industry, and that they were not disclosed in approximately 20% of the instances.

In a 2017 study of 104 large patient advocacy organizations published in The New England Journal of Medicine, Dr. McCoy and colleagues reported that 83% had received funds from industry. At least 39% had a current or former industry executive on the governing board, and 12% had a current or former industry executive in a board leadership position. Of the 104, 38 were focused on cancer and 13 on neurologic conditions. Of these, only 12% had published policies for managing institutional COIs.

Dr. McCoy emphasized the industry’s reliance on partnering with patient groups, particularly during FDA advisory committee meetings. “The sponsors wouldn’t be paying for patients to show up and give these testimonies if they didn’t think it made a difference. The audience isn’t just panel members; it’s also agency officials and maybe elected officials as well.”

“The Fox Foundation, with a $300 million-plus budget, gets about $5-$6 million a year from industry,” said Mr. Thompson. The money is earmarked for the organization’s Parkinson’s Disease Education Consortium; none goes toward advocacy. And, “the foundation has never specifically endorsed a product or device.”

When organizations that receive industry funding back a particular product, “it does appear to be [a conflict], and whether it is an actual one or not, appearances sometimes are all that matter,” said Mr. Thompson.

Dr. Lynch said accepting industry money “is a really significant conflict.” While advocates might need that money to fund advocacy efforts or make grants to advance research priorities, the acceptance might hinder willingness to demand evidence or to complain about a product’s price tag. “You don’t want to bite the hand that feeds you, right?”

Both Dr. McCoy and Dr. Lynch said patient groups — and individual patients — should at a minimum disclose industry funding, especially when speaking at an advisory committee.

Federal agencies and members of Congress actively seek patient input when considering legislation and funding priorities. But the individuals testifying at an advisory committee aren’t likely to represent all patients, and there’s a danger that they are just the loudest voices, said Dr. McCoy.

“We need to think more carefully about how we actually understand the preferences of a big, diverse patient population,” he said.

Dr. Lynch agreed.

Within the ALS community, “a lot of people who take different perspectives than some of those that are the leading voices get shouted down, and their voices get drowned out, and they get attacked on social media,” she said.

The group may be at the table, “but they’re just one voice at the table,” she said.

Dr. McCoy reported that his wife works for the Leukemia & Lymphoma Society, a patient advocacy organization. Dr. Rand reported no relevant financial relationships. Dr. Lynch received funding from Arnold Ventures and the Greenwall Foundation for work related to the FDA and patient advocacy.

A version of this article first appeared on Medscape.com.

Advocacy groups for patients with neurologic disorders have become a common feature in the landscape of drug and device development and federal research funding allocation.

On Capitol Hill, advocates have racked up some impressive legislative wins that aim to set a federal agenda for developing new medications.

At the Food and Drug Administration (FDA), advocacy groups played a significant role in several recent high-profile and controversial approvals for drugs for Alzheimer’s disease, Duchenne muscular dystrophy (DMD), and amyotrophic lateral sclerosis (ALS).

Such gains suggest these groups are growing in power. But with these wins come questions about whether large advocacy organizations — some of which receive significant industry funding — wield too much influence.

“You need to think very carefully about how you open these processes up to greater patient involvement,” Matthew S. McCoy, PhD, assistant professor of medical ethics and health policy at the University of Pennsylvania, Philadelphia, told this news organization. It’s important not to “end up with a situation where it’s the best-connected, the most well-resourced, the most-savvy patient organizations that are able to exercise outsize influence.”

Just because a group has deep pockets does not mean that its priorities align with the disease burden. And not every patient population is represented by a professionalized patient advocacy organization, Dr. McCoy noted. “There is the potential for the rich to get richer.”
 

A Seat at the Table

Long ago, the FDA and the National Institutes of Health (NIH) began giving patients a seat at the table, in part because of the path blazed by AIDS activists in the late 1980s and early 1990s, said Dr. McCoy.

Patient advocacy is often visible during FDA advisory committee meetings. The agency usually allows an hour, sometimes more, for members of the public to express support or concerns about the product being reviewed. Patients and caregivers — often aided by advocacy organizations — also submit hundreds, sometimes thousands, of letters before a product review.

The Alzheimer’s Association spent years advocating for approval of the anti-amyloid agent aducanumab (Aduhelm, Biogen/Eisai). In 2020, the organization urged patients and caregivers to submit written and oral testimony to the FDA advisory panel that was reviewing the drug. Despite patients’ pleas, the panel ultimately declined to support the drug’s approval, citing safety concerns and limited evidence of efficacy.

As controversy swirled around the medication — which had the potential for life-threatening brain swelling — advocates continued to apply pressure. Going against the expert panel’s recommendation, in June 2021, the FDA granted accelerated approval prompting three of the panelists to resign in protest.

Aducanumab’s initial price — $56,000 a year — was seen as a major threat to the viability of Medicare. Still, the Alzheimer’s Association stood behind the decision to approve the drug. But by early 2024, Biogen/Eisai said they would stop selling aducanumab, citing other priorities.

Once again patient advocates showed up in March 2022 when the FDA advisers were reviewing Amylyx Pharmaceuticals’ ALS drug Relyvrio (sodium phenylbutyrate and taurursodiol). Trials had showed limited efficacy, but patients testified they would accept greater risk for a chance to be treated with the drug. The committee ultimately voted against approval; 6 months later, the FDA approved Relyvrio anyway.

In April 2024, Amylyx removed Relyvrio from the market following phase 3 trial results that showed no difference between the treatment and placebo.

The drug manufacturer Sarepta Therapeutics, which develops treatments for genetic conditions such as DMD, has a history of working with — and funding — patient advocacy groups. The company encourages nonprofits to apply for grants or sponsorship on its website. At a 2016 advisory committee, when Sarepta was seeking approval of its first DMD therapy eteplirsen (Exondys 51), 52 speakers, most from patient advocacy groups, pleaded for the drug’s approval. When the panel voted no, Sarepta mobilized families to pressure the agency. Exondys was eventually approved.

In June, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, unilaterally gave final expanded approval to Sarepta Therapeutics’ gene therapy Elevidys for DMD. Dr. Marks overrode his own FDA reviewers, who said the product lacked substantial evidence of efficacy. He acknowledged the drug had not met its primary endpoint but said he found secondary and exploratory endpoints “compelling” and cited an unmet medical need.

In an opinion piece in The Washington Post, Aaron Kesselheim, MD, JD, MPH, the director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, Boston, Massachusetts, and a former member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, questioned the approval stating that it undermined both public trust and manufacturers’ incentives to do the hard work of proving effectiveness.
 

Patient Voices the ‘Secret Sauce’

Drugmakers aren’t alone in seeing the value of having patients speak directly to government entities. When the Michael J. Fox Foundation wanted to gather cosponsors for the National Plan to End Parkinson’s Act, which President Joe Biden signed into law in July, it recruited and trained patients and caregivers for congressional meetings, said Ted Thompson, senior vice president of public policy at the foundation.

Having those individuals “making the personal case for how this disease affects their families ... was really the secret sauce,” in garnering a large number of cosponsors and getting legislation signed into law within 2 years of its introduction, Mr. Thompson told this news organization.

ALS advocacy groups launched a similar campaign to secure passage of the Accelerating Access to Critical Therapies for ALS Act in 2021.

Both pieces of legislation seek to set a federal agenda for developing new therapies in neurodegenerative diseases, in part by directing the FDA and NIH to fund research, engage patients more directly, and form public-private partnerships and councils to spur innovation.

But some said patient advocates are still coming far too late to the party.

“By the time you hear from patient groups at the meetings at the FDA, often the best opportunities for their input are long past,” Leah Zoe Gibson Rand, DPhil, a research scientist with the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, told this news organization. There should be more focus on the patient perspective earlier in drug development and trial design.

“There are some things that the patient voice could uniquely tell the agency,” said Holly Fernandez Lynch, JD, associate professor of medical ethics and health policy at the University of Pennsylvania. Patients can give insight on what it means to live with a disease, what symptoms are particularly burdensome, and which endpoints matter.

But, she said, “listening to the patient voice cannot mean that FDA just steps aside and lets anything on the market that patients are willing to try.” Individuals “who lack good treatment options have a very good reason to want to try things that haven’t yet been proven.”

If the FDA allows drugs on the market just because patients are willing to try, “5 or 10 years down the road, it’s not at all clear that we would end up with drugs that are better, or drugs that work, or drugs that we know anything more about,” said Dr. Lynch.
 

Does Taking Industry Money Equal Conflicts of Interest?

Many patient advocacy organizations receive funding from drug companies, medical device makers, or other industry sources, but they aren’t always transparent about how much or from which companies, according to studies.

The Alzheimer’s Association continued to push for the approval of aducanumab, even as the group received millions of dollars from the drugmakers. The association was accused of failing to disclose the potential conflict. It still lobbied for approval, even after the FDA advisers in 2020 voted against the drug.

It is not uncommon for individuals who speak in favor of a product’s approval to receive money for transportation and/or lodging from the drug’s manufacturer. In 2018, Dr. McCoy and colleagues reported in JAMA Internal Medicine that, between 2009 and 2017, a quarter of the speakers at the Anesthetic and Analgesic Drug Products Advisory Committee had conflicts of interest (COIs), mostly from industry, and that they were not disclosed in approximately 20% of the instances.

In a 2017 study of 104 large patient advocacy organizations published in The New England Journal of Medicine, Dr. McCoy and colleagues reported that 83% had received funds from industry. At least 39% had a current or former industry executive on the governing board, and 12% had a current or former industry executive in a board leadership position. Of the 104, 38 were focused on cancer and 13 on neurologic conditions. Of these, only 12% had published policies for managing institutional COIs.

Dr. McCoy emphasized the industry’s reliance on partnering with patient groups, particularly during FDA advisory committee meetings. “The sponsors wouldn’t be paying for patients to show up and give these testimonies if they didn’t think it made a difference. The audience isn’t just panel members; it’s also agency officials and maybe elected officials as well.”

“The Fox Foundation, with a $300 million-plus budget, gets about $5-$6 million a year from industry,” said Mr. Thompson. The money is earmarked for the organization’s Parkinson’s Disease Education Consortium; none goes toward advocacy. And, “the foundation has never specifically endorsed a product or device.”

When organizations that receive industry funding back a particular product, “it does appear to be [a conflict], and whether it is an actual one or not, appearances sometimes are all that matter,” said Mr. Thompson.

Dr. Lynch said accepting industry money “is a really significant conflict.” While advocates might need that money to fund advocacy efforts or make grants to advance research priorities, the acceptance might hinder willingness to demand evidence or to complain about a product’s price tag. “You don’t want to bite the hand that feeds you, right?”

Both Dr. McCoy and Dr. Lynch said patient groups — and individual patients — should at a minimum disclose industry funding, especially when speaking at an advisory committee.

Federal agencies and members of Congress actively seek patient input when considering legislation and funding priorities. But the individuals testifying at an advisory committee aren’t likely to represent all patients, and there’s a danger that they are just the loudest voices, said Dr. McCoy.

“We need to think more carefully about how we actually understand the preferences of a big, diverse patient population,” he said.

Dr. Lynch agreed.

Within the ALS community, “a lot of people who take different perspectives than some of those that are the leading voices get shouted down, and their voices get drowned out, and they get attacked on social media,” she said.

The group may be at the table, “but they’re just one voice at the table,” she said.

Dr. McCoy reported that his wife works for the Leukemia & Lymphoma Society, a patient advocacy organization. Dr. Rand reported no relevant financial relationships. Dr. Lynch received funding from Arnold Ventures and the Greenwall Foundation for work related to the FDA and patient advocacy.

A version of this article first appeared on Medscape.com.

Advocacy groups for patients with neurologic disorders have become a common feature in the landscape of drug and device development and federal research funding allocation.

On Capitol Hill, advocates have racked up some impressive legislative wins that aim to set a federal agenda for developing new medications.

At the Food and Drug Administration (FDA), advocacy groups played a significant role in several recent high-profile and controversial approvals for drugs for Alzheimer’s disease, Duchenne muscular dystrophy (DMD), and amyotrophic lateral sclerosis (ALS).

Such gains suggest these groups are growing in power. But with these wins come questions about whether large advocacy organizations — some of which receive significant industry funding — wield too much influence.

“You need to think very carefully about how you open these processes up to greater patient involvement,” Matthew S. McCoy, PhD, assistant professor of medical ethics and health policy at the University of Pennsylvania, Philadelphia, told this news organization. It’s important not to “end up with a situation where it’s the best-connected, the most well-resourced, the most-savvy patient organizations that are able to exercise outsize influence.”

Just because a group has deep pockets does not mean that its priorities align with the disease burden. And not every patient population is represented by a professionalized patient advocacy organization, Dr. McCoy noted. “There is the potential for the rich to get richer.”
 

A Seat at the Table

Long ago, the FDA and the National Institutes of Health (NIH) began giving patients a seat at the table, in part because of the path blazed by AIDS activists in the late 1980s and early 1990s, said Dr. McCoy.

Patient advocacy is often visible during FDA advisory committee meetings. The agency usually allows an hour, sometimes more, for members of the public to express support or concerns about the product being reviewed. Patients and caregivers — often aided by advocacy organizations — also submit hundreds, sometimes thousands, of letters before a product review.

The Alzheimer’s Association spent years advocating for approval of the anti-amyloid agent aducanumab (Aduhelm, Biogen/Eisai). In 2020, the organization urged patients and caregivers to submit written and oral testimony to the FDA advisory panel that was reviewing the drug. Despite patients’ pleas, the panel ultimately declined to support the drug’s approval, citing safety concerns and limited evidence of efficacy.

As controversy swirled around the medication — which had the potential for life-threatening brain swelling — advocates continued to apply pressure. Going against the expert panel’s recommendation, in June 2021, the FDA granted accelerated approval prompting three of the panelists to resign in protest.

Aducanumab’s initial price — $56,000 a year — was seen as a major threat to the viability of Medicare. Still, the Alzheimer’s Association stood behind the decision to approve the drug. But by early 2024, Biogen/Eisai said they would stop selling aducanumab, citing other priorities.

Once again patient advocates showed up in March 2022 when the FDA advisers were reviewing Amylyx Pharmaceuticals’ ALS drug Relyvrio (sodium phenylbutyrate and taurursodiol). Trials had showed limited efficacy, but patients testified they would accept greater risk for a chance to be treated with the drug. The committee ultimately voted against approval; 6 months later, the FDA approved Relyvrio anyway.

In April 2024, Amylyx removed Relyvrio from the market following phase 3 trial results that showed no difference between the treatment and placebo.

The drug manufacturer Sarepta Therapeutics, which develops treatments for genetic conditions such as DMD, has a history of working with — and funding — patient advocacy groups. The company encourages nonprofits to apply for grants or sponsorship on its website. At a 2016 advisory committee, when Sarepta was seeking approval of its first DMD therapy eteplirsen (Exondys 51), 52 speakers, most from patient advocacy groups, pleaded for the drug’s approval. When the panel voted no, Sarepta mobilized families to pressure the agency. Exondys was eventually approved.

In June, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, unilaterally gave final expanded approval to Sarepta Therapeutics’ gene therapy Elevidys for DMD. Dr. Marks overrode his own FDA reviewers, who said the product lacked substantial evidence of efficacy. He acknowledged the drug had not met its primary endpoint but said he found secondary and exploratory endpoints “compelling” and cited an unmet medical need.

In an opinion piece in The Washington Post, Aaron Kesselheim, MD, JD, MPH, the director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, Boston, Massachusetts, and a former member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, questioned the approval stating that it undermined both public trust and manufacturers’ incentives to do the hard work of proving effectiveness.
 

Patient Voices the ‘Secret Sauce’

Drugmakers aren’t alone in seeing the value of having patients speak directly to government entities. When the Michael J. Fox Foundation wanted to gather cosponsors for the National Plan to End Parkinson’s Act, which President Joe Biden signed into law in July, it recruited and trained patients and caregivers for congressional meetings, said Ted Thompson, senior vice president of public policy at the foundation.

Having those individuals “making the personal case for how this disease affects their families ... was really the secret sauce,” in garnering a large number of cosponsors and getting legislation signed into law within 2 years of its introduction, Mr. Thompson told this news organization.

ALS advocacy groups launched a similar campaign to secure passage of the Accelerating Access to Critical Therapies for ALS Act in 2021.

Both pieces of legislation seek to set a federal agenda for developing new therapies in neurodegenerative diseases, in part by directing the FDA and NIH to fund research, engage patients more directly, and form public-private partnerships and councils to spur innovation.

But some said patient advocates are still coming far too late to the party.

“By the time you hear from patient groups at the meetings at the FDA, often the best opportunities for their input are long past,” Leah Zoe Gibson Rand, DPhil, a research scientist with the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, told this news organization. There should be more focus on the patient perspective earlier in drug development and trial design.

“There are some things that the patient voice could uniquely tell the agency,” said Holly Fernandez Lynch, JD, associate professor of medical ethics and health policy at the University of Pennsylvania. Patients can give insight on what it means to live with a disease, what symptoms are particularly burdensome, and which endpoints matter.

But, she said, “listening to the patient voice cannot mean that FDA just steps aside and lets anything on the market that patients are willing to try.” Individuals “who lack good treatment options have a very good reason to want to try things that haven’t yet been proven.”

If the FDA allows drugs on the market just because patients are willing to try, “5 or 10 years down the road, it’s not at all clear that we would end up with drugs that are better, or drugs that work, or drugs that we know anything more about,” said Dr. Lynch.
 

Does Taking Industry Money Equal Conflicts of Interest?

Many patient advocacy organizations receive funding from drug companies, medical device makers, or other industry sources, but they aren’t always transparent about how much or from which companies, according to studies.

The Alzheimer’s Association continued to push for the approval of aducanumab, even as the group received millions of dollars from the drugmakers. The association was accused of failing to disclose the potential conflict. It still lobbied for approval, even after the FDA advisers in 2020 voted against the drug.

It is not uncommon for individuals who speak in favor of a product’s approval to receive money for transportation and/or lodging from the drug’s manufacturer. In 2018, Dr. McCoy and colleagues reported in JAMA Internal Medicine that, between 2009 and 2017, a quarter of the speakers at the Anesthetic and Analgesic Drug Products Advisory Committee had conflicts of interest (COIs), mostly from industry, and that they were not disclosed in approximately 20% of the instances.

In a 2017 study of 104 large patient advocacy organizations published in The New England Journal of Medicine, Dr. McCoy and colleagues reported that 83% had received funds from industry. At least 39% had a current or former industry executive on the governing board, and 12% had a current or former industry executive in a board leadership position. Of the 104, 38 were focused on cancer and 13 on neurologic conditions. Of these, only 12% had published policies for managing institutional COIs.

Dr. McCoy emphasized the industry’s reliance on partnering with patient groups, particularly during FDA advisory committee meetings. “The sponsors wouldn’t be paying for patients to show up and give these testimonies if they didn’t think it made a difference. The audience isn’t just panel members; it’s also agency officials and maybe elected officials as well.”

“The Fox Foundation, with a $300 million-plus budget, gets about $5-$6 million a year from industry,” said Mr. Thompson. The money is earmarked for the organization’s Parkinson’s Disease Education Consortium; none goes toward advocacy. And, “the foundation has never specifically endorsed a product or device.”

When organizations that receive industry funding back a particular product, “it does appear to be [a conflict], and whether it is an actual one or not, appearances sometimes are all that matter,” said Mr. Thompson.

Dr. Lynch said accepting industry money “is a really significant conflict.” While advocates might need that money to fund advocacy efforts or make grants to advance research priorities, the acceptance might hinder willingness to demand evidence or to complain about a product’s price tag. “You don’t want to bite the hand that feeds you, right?”

Both Dr. McCoy and Dr. Lynch said patient groups — and individual patients — should at a minimum disclose industry funding, especially when speaking at an advisory committee.

Federal agencies and members of Congress actively seek patient input when considering legislation and funding priorities. But the individuals testifying at an advisory committee aren’t likely to represent all patients, and there’s a danger that they are just the loudest voices, said Dr. McCoy.

“We need to think more carefully about how we actually understand the preferences of a big, diverse patient population,” he said.

Dr. Lynch agreed.

Within the ALS community, “a lot of people who take different perspectives than some of those that are the leading voices get shouted down, and their voices get drowned out, and they get attacked on social media,” she said.

The group may be at the table, “but they’re just one voice at the table,” she said.

Dr. McCoy reported that his wife works for the Leukemia & Lymphoma Society, a patient advocacy organization. Dr. Rand reported no relevant financial relationships. Dr. Lynch received funding from Arnold Ventures and the Greenwall Foundation for work related to the FDA and patient advocacy.

A version of this article first appeared on Medscape.com.

In older individuals with chronic kidney disease (CKD), a higher intake of animal or plant protein is associated with reduced mortality. This finding comes from an analysis of three cohorts from Spain and Sweden, the results of which were published in JAMA Network Open.

In old age, our protein requirement increases. The recommended protein intake is between 1.0 and 1.2 g per kg of actual body weight per day. For elderly patients with acute and chronic illnesses, injuries, or malnutrition, the requirement may be higher.

“While older adults may need more protein than younger persons, higher protein intake could accelerate disease progression among those with CKD, a prevalent condition in older adults that often has no cure and high morbidity and mortality,” wrote Dr. Adrián Carballo-Casla of the Aging Research Center at the Karolinska Institutet in Stockholm, Sweden, and his colleagues.
 

Protein Restriction

The current Kidney Disease: Improving Global Outcomes guideline recommends that patients with mild CKD (ie, stages 1 and 2) not consume more than 1.3 g/kg/day of protein. In stages 3-5 (without dialysis) of CKD, protein intake should be limited to 0.6-0.8 g/kg/day. “Such a regimen of lower protein intake has been shown to slow CKD progression rates and improve metabolic derangements in persons with CKD stages 4 and 5 not receiving dialysis,” the researchers wrote. “Insufficient evidence of the overall health impact of limiting protein intake in older persons with mild or moderate CKD, and whether this impact is different in older adults without CKD, is available.”

The authors analyzed data from three cohorts from Spain and Sweden that included 8543 participants aged at least 60 years. A total of 14,399 observations were analyzed, including 4789 participants with CKD stages 1-3 and 9610 without CKD. To capture protein intake over a longer period and minimize variations among individual study participants, the researchers arranged the data so that there was one observation per time interval for each participant. During the 10-year follow-up, 1468 deaths were documented.

“We observed an inverse association between total protein intake and mortality among participants with CKD but a somewhat weaker one than among those without CKD,” the researchers wrote.
 

Slightly Weaker Association

Compared with participants with a protein intake of 0.8 g/kg/day, participants with CKD who consumed 1.0 g/kg/day of protein had a 12% reduced risk for death. At an intake of 1.2 g/kg/day, the mortality risk decreased by 21%. It decreased by 27% at a protein intake of 1.4 g/kg/day. In patients without CKD, the corresponding risk reductions were 23%, 37%, and 44%.

While in participants without CKD, mortality decreased by 15% with each increase in protein intake of 0.2 g/kg/day, in patients with CKD, the decrease was only 8%.

The association did not change according to whether the protein was of animal or plant origin. The age of the study participants (ie, whether they were under or over age 75 years) also did not play a role.
 

Benefits Outweigh Drawbacks

The researchers pointed out that the biological effects of protein sources could depend on the total intake, as well as the proportion of plant protein in the diet. “Not only did 68% of total protein come from animal sources in our study, but also the mean protein intake was well above the current recommendations for persons with moderate CKD,” they wrote. It is therefore unclear whether the results could be extrapolated to older patients who follow a plant-based or low-protein diet.

“The stronger associations in participants without CKD suggest that the benefits of proteins may outweigh the downsides in older persons with mild or moderate CKD,” the researchers concluded. 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In older individuals with chronic kidney disease (CKD), a higher intake of animal or plant protein is associated with reduced mortality. This finding comes from an analysis of three cohorts from Spain and Sweden, the results of which were published in JAMA Network Open.

In old age, our protein requirement increases. The recommended protein intake is between 1.0 and 1.2 g per kg of actual body weight per day. For elderly patients with acute and chronic illnesses, injuries, or malnutrition, the requirement may be higher.

“While older adults may need more protein than younger persons, higher protein intake could accelerate disease progression among those with CKD, a prevalent condition in older adults that often has no cure and high morbidity and mortality,” wrote Dr. Adrián Carballo-Casla of the Aging Research Center at the Karolinska Institutet in Stockholm, Sweden, and his colleagues.
 

Protein Restriction

The current Kidney Disease: Improving Global Outcomes guideline recommends that patients with mild CKD (ie, stages 1 and 2) not consume more than 1.3 g/kg/day of protein. In stages 3-5 (without dialysis) of CKD, protein intake should be limited to 0.6-0.8 g/kg/day. “Such a regimen of lower protein intake has been shown to slow CKD progression rates and improve metabolic derangements in persons with CKD stages 4 and 5 not receiving dialysis,” the researchers wrote. “Insufficient evidence of the overall health impact of limiting protein intake in older persons with mild or moderate CKD, and whether this impact is different in older adults without CKD, is available.”

The authors analyzed data from three cohorts from Spain and Sweden that included 8543 participants aged at least 60 years. A total of 14,399 observations were analyzed, including 4789 participants with CKD stages 1-3 and 9610 without CKD. To capture protein intake over a longer period and minimize variations among individual study participants, the researchers arranged the data so that there was one observation per time interval for each participant. During the 10-year follow-up, 1468 deaths were documented.

“We observed an inverse association between total protein intake and mortality among participants with CKD but a somewhat weaker one than among those without CKD,” the researchers wrote.
 

Slightly Weaker Association

Compared with participants with a protein intake of 0.8 g/kg/day, participants with CKD who consumed 1.0 g/kg/day of protein had a 12% reduced risk for death. At an intake of 1.2 g/kg/day, the mortality risk decreased by 21%. It decreased by 27% at a protein intake of 1.4 g/kg/day. In patients without CKD, the corresponding risk reductions were 23%, 37%, and 44%.

While in participants without CKD, mortality decreased by 15% with each increase in protein intake of 0.2 g/kg/day, in patients with CKD, the decrease was only 8%.

The association did not change according to whether the protein was of animal or plant origin. The age of the study participants (ie, whether they were under or over age 75 years) also did not play a role.
 

Benefits Outweigh Drawbacks

The researchers pointed out that the biological effects of protein sources could depend on the total intake, as well as the proportion of plant protein in the diet. “Not only did 68% of total protein come from animal sources in our study, but also the mean protein intake was well above the current recommendations for persons with moderate CKD,” they wrote. It is therefore unclear whether the results could be extrapolated to older patients who follow a plant-based or low-protein diet.

“The stronger associations in participants without CKD suggest that the benefits of proteins may outweigh the downsides in older persons with mild or moderate CKD,” the researchers concluded. 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In older individuals with chronic kidney disease (CKD), a higher intake of animal or plant protein is associated with reduced mortality. This finding comes from an analysis of three cohorts from Spain and Sweden, the results of which were published in JAMA Network Open.

In old age, our protein requirement increases. The recommended protein intake is between 1.0 and 1.2 g per kg of actual body weight per day. For elderly patients with acute and chronic illnesses, injuries, or malnutrition, the requirement may be higher.

“While older adults may need more protein than younger persons, higher protein intake could accelerate disease progression among those with CKD, a prevalent condition in older adults that often has no cure and high morbidity and mortality,” wrote Dr. Adrián Carballo-Casla of the Aging Research Center at the Karolinska Institutet in Stockholm, Sweden, and his colleagues.
 

Protein Restriction

The current Kidney Disease: Improving Global Outcomes guideline recommends that patients with mild CKD (ie, stages 1 and 2) not consume more than 1.3 g/kg/day of protein. In stages 3-5 (without dialysis) of CKD, protein intake should be limited to 0.6-0.8 g/kg/day. “Such a regimen of lower protein intake has been shown to slow CKD progression rates and improve metabolic derangements in persons with CKD stages 4 and 5 not receiving dialysis,” the researchers wrote. “Insufficient evidence of the overall health impact of limiting protein intake in older persons with mild or moderate CKD, and whether this impact is different in older adults without CKD, is available.”

The authors analyzed data from three cohorts from Spain and Sweden that included 8543 participants aged at least 60 years. A total of 14,399 observations were analyzed, including 4789 participants with CKD stages 1-3 and 9610 without CKD. To capture protein intake over a longer period and minimize variations among individual study participants, the researchers arranged the data so that there was one observation per time interval for each participant. During the 10-year follow-up, 1468 deaths were documented.

“We observed an inverse association between total protein intake and mortality among participants with CKD but a somewhat weaker one than among those without CKD,” the researchers wrote.
 

Slightly Weaker Association

Compared with participants with a protein intake of 0.8 g/kg/day, participants with CKD who consumed 1.0 g/kg/day of protein had a 12% reduced risk for death. At an intake of 1.2 g/kg/day, the mortality risk decreased by 21%. It decreased by 27% at a protein intake of 1.4 g/kg/day. In patients without CKD, the corresponding risk reductions were 23%, 37%, and 44%.

While in participants without CKD, mortality decreased by 15% with each increase in protein intake of 0.2 g/kg/day, in patients with CKD, the decrease was only 8%.

The association did not change according to whether the protein was of animal or plant origin. The age of the study participants (ie, whether they were under or over age 75 years) also did not play a role.
 

Benefits Outweigh Drawbacks

The researchers pointed out that the biological effects of protein sources could depend on the total intake, as well as the proportion of plant protein in the diet. “Not only did 68% of total protein come from animal sources in our study, but also the mean protein intake was well above the current recommendations for persons with moderate CKD,” they wrote. It is therefore unclear whether the results could be extrapolated to older patients who follow a plant-based or low-protein diet.

“The stronger associations in participants without CKD suggest that the benefits of proteins may outweigh the downsides in older persons with mild or moderate CKD,” the researchers concluded. 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Researchers detail best practices for pediatricians in evaluating dental indications of child abuse and how to work with other physicians to detect and report these incidents.

METHODOLOGY:

• Approximately 323,000 children in the United States were identified as having experienced physical abuse in 2006, the most recent year evaluated, according to the Fourth National Incidence Study of Child Abuse and Neglect.
• One in seven children in the United States are abused or neglected each year; craniofacial, head, face, and neck injuries occur in more than half of child abuse cases.
• Children with orofacial and torso bruising who are younger than age 4 years are at risk for future, more serious abuse.
• Child trafficking survivors are twice as likely to have dental issues due to poor nutrition and inadequate care.

TAKEAWAY:

• In cases of possible oral sexual abuse, physicians should test for sexually transmitted infections and document incidents to support forensic investigations.
• Pediatricians should consult with forensic pediatric dentists or child abuse specialists for assistance in evaluating bite marks or any other indications of abuse.
• If a parent fails to seek treatment for a child’s oral or dental disease after detection, pediatricians should report the case to child protective services regarding concerns of dental neglect.
• Because trafficked children may receive medical or dental care while in captivity, physicians should use screening tools to identify children at risk of trafficking, regardless of gender.
• Physicians should be mindful of having a bias against reporting because of sharing a similar background to the parents or other caregivers of a child who is suspected of experiencing abuse.

IN PRACTICE:

“Pediatric dentists and oral and maxillofacial surgeons, whose advanced education programs include a mandated child abuse curriculum, can provide valuable information and assistance to other health care providers about oral and dental aspects of child abuse and neglect,” the study authors wrote.

SOURCE:

The study was led by Anupama Rao Tate, DMD, MPH, of the American Academy of Pediatrics, and was published online in Pediatrics.

LIMITATIONS:

No limitations were reported.

DISCLOSURES:

Susan A. Fischer-Owens reported financial connections with Colgate. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers detail best practices for pediatricians in evaluating dental indications of child abuse and how to work with other physicians to detect and report these incidents.

METHODOLOGY:

• Approximately 323,000 children in the United States were identified as having experienced physical abuse in 2006, the most recent year evaluated, according to the Fourth National Incidence Study of Child Abuse and Neglect.
• One in seven children in the United States are abused or neglected each year; craniofacial, head, face, and neck injuries occur in more than half of child abuse cases.
• Children with orofacial and torso bruising who are younger than age 4 years are at risk for future, more serious abuse.
• Child trafficking survivors are twice as likely to have dental issues due to poor nutrition and inadequate care.

TAKEAWAY:

• In cases of possible oral sexual abuse, physicians should test for sexually transmitted infections and document incidents to support forensic investigations.
• Pediatricians should consult with forensic pediatric dentists or child abuse specialists for assistance in evaluating bite marks or any other indications of abuse.
• If a parent fails to seek treatment for a child’s oral or dental disease after detection, pediatricians should report the case to child protective services regarding concerns of dental neglect.
• Because trafficked children may receive medical or dental care while in captivity, physicians should use screening tools to identify children at risk of trafficking, regardless of gender.
• Physicians should be mindful of having a bias against reporting because of sharing a similar background to the parents or other caregivers of a child who is suspected of experiencing abuse.

IN PRACTICE:

“Pediatric dentists and oral and maxillofacial surgeons, whose advanced education programs include a mandated child abuse curriculum, can provide valuable information and assistance to other health care providers about oral and dental aspects of child abuse and neglect,” the study authors wrote.

SOURCE:

The study was led by Anupama Rao Tate, DMD, MPH, of the American Academy of Pediatrics, and was published online in Pediatrics.

LIMITATIONS:

No limitations were reported.

DISCLOSURES:

Susan A. Fischer-Owens reported financial connections with Colgate. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers detail best practices for pediatricians in evaluating dental indications of child abuse and how to work with other physicians to detect and report these incidents.

METHODOLOGY:

• Approximately 323,000 children in the United States were identified as having experienced physical abuse in 2006, the most recent year evaluated, according to the Fourth National Incidence Study of Child Abuse and Neglect.
• One in seven children in the United States are abused or neglected each year; craniofacial, head, face, and neck injuries occur in more than half of child abuse cases.
• Children with orofacial and torso bruising who are younger than age 4 years are at risk for future, more serious abuse.
• Child trafficking survivors are twice as likely to have dental issues due to poor nutrition and inadequate care.

TAKEAWAY:

• In cases of possible oral sexual abuse, physicians should test for sexually transmitted infections and document incidents to support forensic investigations.
• Pediatricians should consult with forensic pediatric dentists or child abuse specialists for assistance in evaluating bite marks or any other indications of abuse.
• If a parent fails to seek treatment for a child’s oral or dental disease after detection, pediatricians should report the case to child protective services regarding concerns of dental neglect.
• Because trafficked children may receive medical or dental care while in captivity, physicians should use screening tools to identify children at risk of trafficking, regardless of gender.
• Physicians should be mindful of having a bias against reporting because of sharing a similar background to the parents or other caregivers of a child who is suspected of experiencing abuse.

IN PRACTICE:

“Pediatric dentists and oral and maxillofacial surgeons, whose advanced education programs include a mandated child abuse curriculum, can provide valuable information and assistance to other health care providers about oral and dental aspects of child abuse and neglect,” the study authors wrote.

SOURCE:

The study was led by Anupama Rao Tate, DMD, MPH, of the American Academy of Pediatrics, and was published online in Pediatrics.

LIMITATIONS:

No limitations were reported.

DISCLOSURES:

Susan A. Fischer-Owens reported financial connections with Colgate. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Clinicians continue to argue that solely focusing on weight in discussions with patients with obesity can be harmful. But with highly effective agents like semaglutide and tirzepatide, more discussions are being had about obesity, in and out of the doctor’s office. 

In this time of new therapeutic options, it’s critical to be thoughtful in how we broach the topic of weight management and obesity treatments with our patients.

With a stigmatized topic like obesity, it’s not surprising that there is contention surrounding the issue. Weight stigma and discrimination persist worldwide, even though there is ample scientific evidence that weight regulation is strongly determined by uncontrollable factors. 

However, the debate to discuss weight or not doesn’t need to be polarized. There is a common denominator: Help patients live healthy, long lives. Let’s review the principles of the various approaches to care.
 

Chronic Disease–Centric Paradigm

Historically, physicians have addressed and managed chronic diseases, such as type 2 diabetes, hypertension, and dyslipidemia. Even though obesity is a known risk factor for these conditions and can cause many other diseases through low-grade chronic inflammation issues and organ dysfunction, weight management treatment was an afterthought or never entertained.

During my training, I often wondered why we focused on prescribing medications for multiple chronic diseases instead of addressing obesity directly, which could potentially improve all these conditions. 

There are numerous reasons why this paradigm was viewed as the “standard of care” for so many decades. First, it provided a framework for managing an ever-growing list of chronic diseases. And even though the American Medical Association declared obesity a disease in 2013, this was not widely accepted in the healthcare community. 

Healthcare systems and the US reimbursement model have been aligned with a chronic disease treatment paradigm. At the same time, healthcare professionals, like others in society, harbor prejudices. These have presented significant barriers to providing weight management care. 

Additionally, medical education was, and remains, inadequate in training physicians how to prevent and treat obesity.
 

Weight-Centric Paradigm

The literature defines a weight-centric approach to care as one that places significant emphasis on body weight as a primary indicator of health — a perspective that may view lower body weight as inherently healthier. This approach includes comprehensive treatment of obesity that factors in lifestyle, pharmacotherapy, procedures, and surgery. A weight-centric approach has been described as having six tenets, examples of which are “weight is mostly volitional and within the control of the individual,” and “excess body weight causes disease and premature death.” This approach heavily relies on body mass index (BMI) as an indicator of a patients’ current and future health status. 

We know that using BMI as a measure of health has inherent limitations. Recent recommendations suggest that it be used alongside other measurements and assessments, such as waist circumference and waist-to-hip ratio. One major concern with the paradigm, however, is that it can perpetuate weight stigmatization through an overemphasis on weight vs global health. The definition doesn’t acknowledge the wealth of data demonstrating the associated risk increased that central adiposity poses for increased morbidity and mortality. The answer needs to be more nuanced.

Instead of watering down a “weight-centric approach” to be equated with “weight equals health,” I propose it could mean addressing obesity upstream (ie, an adipose-centric approach) to prevent associated morbidity and mortality downstream. 

Also, measuring a patient’s weight in the clinic would be an impartial act, obtaining a routine data point, like measuring a person’s blood pressure. Just as it is necessary to obtain a patient’s blood pressure data to treat hypertension, it is necessary to obtain adiposity health-related data (eg, weight, waist circumference, neck circumference, waist-to-hip ratio, weight history, physical exam, lab tests) to make informed clinical decisions and safeguard delivery of evidence-based care. 

A weight-centric approach is a positive shift from focusing solely on chronic diseases because it allows us to address obesity and explore treatment options. However, challenges remain with this approach in ensuring that weight management discussions are handled holistically, without bias, and with sensitivity. 
 

Weight-Inclusive Paradigm

A weight-inclusive approach promotes overall health and well-being while providing nonstigmatizing care to patients. There is an emphasis on respect for body diversity, with advocacy for body size acceptance and body positivity. When I use this approach in my clinical practice, I emphasize to patients that the ultimate goal we are striving for is improved health and not a particular number on the scale or particular body type. 

This approach supports equal treatment and access to healthcare for all individuals. At its core, the weight inclusive paradigm is a holistic, nonbiased approach to all patients, regardless of body size. For this reason, I use a patient-centered treatment plan with my patients that is comprehensive, is multipronged, and considers all tools available in the toolbox indicated for that individual. 

The weight-inclusive paradigm has much in common with the principles of Health at Every Size. Both share common goals of focusing on health rather than weight, challenging weight stigma and weight discrimination.

Because a weight-inclusive approach encourages body acceptance, some contend that this leads to disregard of the risk that visceral adiposity poses for increased morbidity and mortality. But this is not an either/or situation. Healthcare professionals can accept individuals for who they are regardless of body size and, with patient permission, address obesity in the context of broader health considerations with an individualized, patient-centered treatment plan.
 

Human-Inclusive and Health-Centered Paradigm

Appreciating the evolution of healthcare delivery paradigms, and with greater understanding of the pathophysiology of obesity and arrival of newer, effective treatments, I propose a human-inclusive and health-centered (HIHC) approach to patient care. This model weaves together the fundamental theme of a focus on health, not weight, and aligns with the Hippocratic Oath: to treat patients to the best of our ability and do no harm. 

Unfortunately, history has played out differently. Owing to a confluence of variables, from a lack of training in obesity treatment to a societal obsession with thinness that fosters an anti-fat bias culture, patients have unduly endured tremendous shame and blame for living with overweight and obesity over the years. Now is our chance to do better.

It is our responsibility as healthcare professionals to provide bias-free, patient-centered care to each and every patient, no matter their race, ethnicity, sexual orientation, religion, or body shape and size. Why limit the phrasing to “weight inclusive” when we should strive for a “human inclusive” approach?

When it comes to discussing weight with patients, there is no universally established methodology to introducing the topic. Still, recommended strategies do exist. And we know that individuals with obesity who experience weight bias and stigma have increased morbidity and mortality, regardless of their weight or BMI.

Hence, we must generate compassionate and respectful conversations, free of judgment and bias, when discussing obesity and obesity treatments with patients. Let’s ensure we broaden the discussion beyond weight; acknowledge social determinants of health; and empower individuals to make choices that support their overall health, functionality, and quality of life. 

As we embark on an HIHC paradigm, it will be important not to swing into healthism, whereby those who aren’t healthy or those who don’t pursue health are stigmatized as being less-than. Preserving dignity means accepting patient autonomy and choices. 

I think we all want the same thing: acceptance of all, access to healthcare for all, and bias-free support of patients to live healthy lives. Let’s do this.

Dr. Velazquez, assistant professor of surgery and medicine, Cedars-Sinai Medical Center, and director of obesity medicine, Department of Surgery, Cedars-Sinai Center for Weight Management and Metabolic Health, Los Angeles, California, disclosed ties with Intellihealth, Weight Watchers, Novo Nordisk, and Lilly. She received a research grant from NIH Grant — National Heart, Lung, and Blood Institute (NCT0517662).

A version of this article appeared on Medscape.com.

Clinicians continue to argue that solely focusing on weight in discussions with patients with obesity can be harmful. But with highly effective agents like semaglutide and tirzepatide, more discussions are being had about obesity, in and out of the doctor’s office. 

In this time of new therapeutic options, it’s critical to be thoughtful in how we broach the topic of weight management and obesity treatments with our patients.

With a stigmatized topic like obesity, it’s not surprising that there is contention surrounding the issue. Weight stigma and discrimination persist worldwide, even though there is ample scientific evidence that weight regulation is strongly determined by uncontrollable factors. 

However, the debate to discuss weight or not doesn’t need to be polarized. There is a common denominator: Help patients live healthy, long lives. Let’s review the principles of the various approaches to care.
 

Chronic Disease–Centric Paradigm

Historically, physicians have addressed and managed chronic diseases, such as type 2 diabetes, hypertension, and dyslipidemia. Even though obesity is a known risk factor for these conditions and can cause many other diseases through low-grade chronic inflammation issues and organ dysfunction, weight management treatment was an afterthought or never entertained.

During my training, I often wondered why we focused on prescribing medications for multiple chronic diseases instead of addressing obesity directly, which could potentially improve all these conditions. 

There are numerous reasons why this paradigm was viewed as the “standard of care” for so many decades. First, it provided a framework for managing an ever-growing list of chronic diseases. And even though the American Medical Association declared obesity a disease in 2013, this was not widely accepted in the healthcare community. 

Healthcare systems and the US reimbursement model have been aligned with a chronic disease treatment paradigm. At the same time, healthcare professionals, like others in society, harbor prejudices. These have presented significant barriers to providing weight management care. 

Additionally, medical education was, and remains, inadequate in training physicians how to prevent and treat obesity.
 

Weight-Centric Paradigm

The literature defines a weight-centric approach to care as one that places significant emphasis on body weight as a primary indicator of health — a perspective that may view lower body weight as inherently healthier. This approach includes comprehensive treatment of obesity that factors in lifestyle, pharmacotherapy, procedures, and surgery. A weight-centric approach has been described as having six tenets, examples of which are “weight is mostly volitional and within the control of the individual,” and “excess body weight causes disease and premature death.” This approach heavily relies on body mass index (BMI) as an indicator of a patients’ current and future health status. 

We know that using BMI as a measure of health has inherent limitations. Recent recommendations suggest that it be used alongside other measurements and assessments, such as waist circumference and waist-to-hip ratio. One major concern with the paradigm, however, is that it can perpetuate weight stigmatization through an overemphasis on weight vs global health. The definition doesn’t acknowledge the wealth of data demonstrating the associated risk increased that central adiposity poses for increased morbidity and mortality. The answer needs to be more nuanced.

Instead of watering down a “weight-centric approach” to be equated with “weight equals health,” I propose it could mean addressing obesity upstream (ie, an adipose-centric approach) to prevent associated morbidity and mortality downstream. 

Also, measuring a patient’s weight in the clinic would be an impartial act, obtaining a routine data point, like measuring a person’s blood pressure. Just as it is necessary to obtain a patient’s blood pressure data to treat hypertension, it is necessary to obtain adiposity health-related data (eg, weight, waist circumference, neck circumference, waist-to-hip ratio, weight history, physical exam, lab tests) to make informed clinical decisions and safeguard delivery of evidence-based care. 

A weight-centric approach is a positive shift from focusing solely on chronic diseases because it allows us to address obesity and explore treatment options. However, challenges remain with this approach in ensuring that weight management discussions are handled holistically, without bias, and with sensitivity. 
 

Weight-Inclusive Paradigm

A weight-inclusive approach promotes overall health and well-being while providing nonstigmatizing care to patients. There is an emphasis on respect for body diversity, with advocacy for body size acceptance and body positivity. When I use this approach in my clinical practice, I emphasize to patients that the ultimate goal we are striving for is improved health and not a particular number on the scale or particular body type. 

This approach supports equal treatment and access to healthcare for all individuals. At its core, the weight inclusive paradigm is a holistic, nonbiased approach to all patients, regardless of body size. For this reason, I use a patient-centered treatment plan with my patients that is comprehensive, is multipronged, and considers all tools available in the toolbox indicated for that individual. 

The weight-inclusive paradigm has much in common with the principles of Health at Every Size. Both share common goals of focusing on health rather than weight, challenging weight stigma and weight discrimination.

Because a weight-inclusive approach encourages body acceptance, some contend that this leads to disregard of the risk that visceral adiposity poses for increased morbidity and mortality. But this is not an either/or situation. Healthcare professionals can accept individuals for who they are regardless of body size and, with patient permission, address obesity in the context of broader health considerations with an individualized, patient-centered treatment plan.
 

Human-Inclusive and Health-Centered Paradigm

Appreciating the evolution of healthcare delivery paradigms, and with greater understanding of the pathophysiology of obesity and arrival of newer, effective treatments, I propose a human-inclusive and health-centered (HIHC) approach to patient care. This model weaves together the fundamental theme of a focus on health, not weight, and aligns with the Hippocratic Oath: to treat patients to the best of our ability and do no harm. 

Unfortunately, history has played out differently. Owing to a confluence of variables, from a lack of training in obesity treatment to a societal obsession with thinness that fosters an anti-fat bias culture, patients have unduly endured tremendous shame and blame for living with overweight and obesity over the years. Now is our chance to do better.

It is our responsibility as healthcare professionals to provide bias-free, patient-centered care to each and every patient, no matter their race, ethnicity, sexual orientation, religion, or body shape and size. Why limit the phrasing to “weight inclusive” when we should strive for a “human inclusive” approach?

When it comes to discussing weight with patients, there is no universally established methodology to introducing the topic. Still, recommended strategies do exist. And we know that individuals with obesity who experience weight bias and stigma have increased morbidity and mortality, regardless of their weight or BMI.

Hence, we must generate compassionate and respectful conversations, free of judgment and bias, when discussing obesity and obesity treatments with patients. Let’s ensure we broaden the discussion beyond weight; acknowledge social determinants of health; and empower individuals to make choices that support their overall health, functionality, and quality of life. 

As we embark on an HIHC paradigm, it will be important not to swing into healthism, whereby those who aren’t healthy or those who don’t pursue health are stigmatized as being less-than. Preserving dignity means accepting patient autonomy and choices. 

I think we all want the same thing: acceptance of all, access to healthcare for all, and bias-free support of patients to live healthy lives. Let’s do this.

Dr. Velazquez, assistant professor of surgery and medicine, Cedars-Sinai Medical Center, and director of obesity medicine, Department of Surgery, Cedars-Sinai Center for Weight Management and Metabolic Health, Los Angeles, California, disclosed ties with Intellihealth, Weight Watchers, Novo Nordisk, and Lilly. She received a research grant from NIH Grant — National Heart, Lung, and Blood Institute (NCT0517662).

A version of this article appeared on Medscape.com.

Clinicians continue to argue that solely focusing on weight in discussions with patients with obesity can be harmful. But with highly effective agents like semaglutide and tirzepatide, more discussions are being had about obesity, in and out of the doctor’s office. 

In this time of new therapeutic options, it’s critical to be thoughtful in how we broach the topic of weight management and obesity treatments with our patients.

With a stigmatized topic like obesity, it’s not surprising that there is contention surrounding the issue. Weight stigma and discrimination persist worldwide, even though there is ample scientific evidence that weight regulation is strongly determined by uncontrollable factors. 

However, the debate to discuss weight or not doesn’t need to be polarized. There is a common denominator: Help patients live healthy, long lives. Let’s review the principles of the various approaches to care.
 

Chronic Disease–Centric Paradigm

Historically, physicians have addressed and managed chronic diseases, such as type 2 diabetes, hypertension, and dyslipidemia. Even though obesity is a known risk factor for these conditions and can cause many other diseases through low-grade chronic inflammation issues and organ dysfunction, weight management treatment was an afterthought or never entertained.

During my training, I often wondered why we focused on prescribing medications for multiple chronic diseases instead of addressing obesity directly, which could potentially improve all these conditions. 

There are numerous reasons why this paradigm was viewed as the “standard of care” for so many decades. First, it provided a framework for managing an ever-growing list of chronic diseases. And even though the American Medical Association declared obesity a disease in 2013, this was not widely accepted in the healthcare community. 

Healthcare systems and the US reimbursement model have been aligned with a chronic disease treatment paradigm. At the same time, healthcare professionals, like others in society, harbor prejudices. These have presented significant barriers to providing weight management care. 

Additionally, medical education was, and remains, inadequate in training physicians how to prevent and treat obesity.
 

Weight-Centric Paradigm

The literature defines a weight-centric approach to care as one that places significant emphasis on body weight as a primary indicator of health — a perspective that may view lower body weight as inherently healthier. This approach includes comprehensive treatment of obesity that factors in lifestyle, pharmacotherapy, procedures, and surgery. A weight-centric approach has been described as having six tenets, examples of which are “weight is mostly volitional and within the control of the individual,” and “excess body weight causes disease and premature death.” This approach heavily relies on body mass index (BMI) as an indicator of a patients’ current and future health status. 

We know that using BMI as a measure of health has inherent limitations. Recent recommendations suggest that it be used alongside other measurements and assessments, such as waist circumference and waist-to-hip ratio. One major concern with the paradigm, however, is that it can perpetuate weight stigmatization through an overemphasis on weight vs global health. The definition doesn’t acknowledge the wealth of data demonstrating the associated risk increased that central adiposity poses for increased morbidity and mortality. The answer needs to be more nuanced.

Instead of watering down a “weight-centric approach” to be equated with “weight equals health,” I propose it could mean addressing obesity upstream (ie, an adipose-centric approach) to prevent associated morbidity and mortality downstream. 

Also, measuring a patient’s weight in the clinic would be an impartial act, obtaining a routine data point, like measuring a person’s blood pressure. Just as it is necessary to obtain a patient’s blood pressure data to treat hypertension, it is necessary to obtain adiposity health-related data (eg, weight, waist circumference, neck circumference, waist-to-hip ratio, weight history, physical exam, lab tests) to make informed clinical decisions and safeguard delivery of evidence-based care. 

A weight-centric approach is a positive shift from focusing solely on chronic diseases because it allows us to address obesity and explore treatment options. However, challenges remain with this approach in ensuring that weight management discussions are handled holistically, without bias, and with sensitivity. 
 

Weight-Inclusive Paradigm

A weight-inclusive approach promotes overall health and well-being while providing nonstigmatizing care to patients. There is an emphasis on respect for body diversity, with advocacy for body size acceptance and body positivity. When I use this approach in my clinical practice, I emphasize to patients that the ultimate goal we are striving for is improved health and not a particular number on the scale or particular body type. 

This approach supports equal treatment and access to healthcare for all individuals. At its core, the weight inclusive paradigm is a holistic, nonbiased approach to all patients, regardless of body size. For this reason, I use a patient-centered treatment plan with my patients that is comprehensive, is multipronged, and considers all tools available in the toolbox indicated for that individual. 

The weight-inclusive paradigm has much in common with the principles of Health at Every Size. Both share common goals of focusing on health rather than weight, challenging weight stigma and weight discrimination.

Because a weight-inclusive approach encourages body acceptance, some contend that this leads to disregard of the risk that visceral adiposity poses for increased morbidity and mortality. But this is not an either/or situation. Healthcare professionals can accept individuals for who they are regardless of body size and, with patient permission, address obesity in the context of broader health considerations with an individualized, patient-centered treatment plan.
 

Human-Inclusive and Health-Centered Paradigm

Appreciating the evolution of healthcare delivery paradigms, and with greater understanding of the pathophysiology of obesity and arrival of newer, effective treatments, I propose a human-inclusive and health-centered (HIHC) approach to patient care. This model weaves together the fundamental theme of a focus on health, not weight, and aligns with the Hippocratic Oath: to treat patients to the best of our ability and do no harm. 

Unfortunately, history has played out differently. Owing to a confluence of variables, from a lack of training in obesity treatment to a societal obsession with thinness that fosters an anti-fat bias culture, patients have unduly endured tremendous shame and blame for living with overweight and obesity over the years. Now is our chance to do better.

It is our responsibility as healthcare professionals to provide bias-free, patient-centered care to each and every patient, no matter their race, ethnicity, sexual orientation, religion, or body shape and size. Why limit the phrasing to “weight inclusive” when we should strive for a “human inclusive” approach?

When it comes to discussing weight with patients, there is no universally established methodology to introducing the topic. Still, recommended strategies do exist. And we know that individuals with obesity who experience weight bias and stigma have increased morbidity and mortality, regardless of their weight or BMI.

Hence, we must generate compassionate and respectful conversations, free of judgment and bias, when discussing obesity and obesity treatments with patients. Let’s ensure we broaden the discussion beyond weight; acknowledge social determinants of health; and empower individuals to make choices that support their overall health, functionality, and quality of life. 

As we embark on an HIHC paradigm, it will be important not to swing into healthism, whereby those who aren’t healthy or those who don’t pursue health are stigmatized as being less-than. Preserving dignity means accepting patient autonomy and choices. 

I think we all want the same thing: acceptance of all, access to healthcare for all, and bias-free support of patients to live healthy lives. Let’s do this.

Dr. Velazquez, assistant professor of surgery and medicine, Cedars-Sinai Medical Center, and director of obesity medicine, Department of Surgery, Cedars-Sinai Center for Weight Management and Metabolic Health, Los Angeles, California, disclosed ties with Intellihealth, Weight Watchers, Novo Nordisk, and Lilly. She received a research grant from NIH Grant — National Heart, Lung, and Blood Institute (NCT0517662).

A version of this article appeared on Medscape.com.

TOPLINE:

Around one in seven Medicare beneficiaries with a high body mass index (BMI) may be newly eligible for semaglutide treatment after Medicare allowed Part D plans to cover the drug for patients with a BMI ≥ 27 and a history of cardiovascular disease (CVD), regardless of their diabetes status.

METHODOLOGY:

• In March 2024, Medicare approved the coverage of semaglutide by Part D plans for patients with a high BMI and existing CVD, irrespective of their diabetes status. This decision follows the SELECT trial results, showing that semaglutide lowered the risk for cardiovascular events in some patients without diabetes.
• This study aimed to describe the Medicare beneficiaries most likely to be newly eligible for semaglutide treatment and estimated maximum costs to Medicare Part D.
• The researchers included 5111 individuals aged ≥ 65 years with self-reported Medicare enrollment in the National Health and Nutrition Examination Survey between 2011 and 2020, all of whom had a BMI ≥ 27 and were likely to benefit from semaglutide treatment.
• They evaluated the following potential definitions of established CVD that could be considered by the Part D plan: physician-provided diagnosis of myocardial infarction, stroke, coronary artery disease, or angina; a 10-year risk for atherosclerotic CVD between 7.5% and < 20.0%; a 10-year risk for atherosclerotic CVD of ≥ 20%; or fulfillment of any of the previous three criteria.
• Data on interview responses, medication use, clinical examinations, laboratory results, and diabetes diagnoses were obtained from the participants.

TAKEAWAY:

• This study found that 3.6 million individuals (14.2%) were deemed highly likely to qualify for semaglutide treatment for the first time, and broadening the criteria for established CVD could increase this number to 15.2 million individuals (60.9%).
• If all newly eligible beneficiaries were to receive semaglutide treatment, Medicare spending could increase by $34-$145 billion annually.
• Even with more conservative definitions of CVD and a significant portion of individuals not maintaining long-term adherence to semaglutide treatment, costs could still increase by $10 billion annually.
• Younger, generally healthier, female Medicare beneficiaries were still likely to remain ineligible for semaglutide treatment according to the coverage provided by Part D Medicare plans.

IN PRACTICE:

“Although approximately one in seven Medicare beneficiaries with elevated BMI is likely to be newly eligible for semaglutide, the majority will remain ineligible if a narrow definition of established CVD is used by Part D plans. Weight control has benefits for patients with elevated BMI, so the definition of established CVD used by Part D plans for coverage of semaglutide could have outsized public health implications,” the authors wrote.

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women’s Hospital, Boston. It was published online in Annals of Internal Medicine.

LIMITATIONS: 

This analysis relied on self-reported cases of CVD. The study was also limited to only community-dwelling adults. It estimated maximum budgetary impacts but did not account for payment reforms introduced by the Inflation Reduction Act or for absolute contraindications to semaglutide.

DISCLOSURES:

This study did not disclose any sources of funding. Some authors declared receiving grants, serving as consultants, and having other ties with some institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Around one in seven Medicare beneficiaries with a high body mass index (BMI) may be newly eligible for semaglutide treatment after Medicare allowed Part D plans to cover the drug for patients with a BMI ≥ 27 and a history of cardiovascular disease (CVD), regardless of their diabetes status.

METHODOLOGY:

• In March 2024, Medicare approved the coverage of semaglutide by Part D plans for patients with a high BMI and existing CVD, irrespective of their diabetes status. This decision follows the SELECT trial results, showing that semaglutide lowered the risk for cardiovascular events in some patients without diabetes.
• This study aimed to describe the Medicare beneficiaries most likely to be newly eligible for semaglutide treatment and estimated maximum costs to Medicare Part D.
• The researchers included 5111 individuals aged ≥ 65 years with self-reported Medicare enrollment in the National Health and Nutrition Examination Survey between 2011 and 2020, all of whom had a BMI ≥ 27 and were likely to benefit from semaglutide treatment.
• They evaluated the following potential definitions of established CVD that could be considered by the Part D plan: physician-provided diagnosis of myocardial infarction, stroke, coronary artery disease, or angina; a 10-year risk for atherosclerotic CVD between 7.5% and < 20.0%; a 10-year risk for atherosclerotic CVD of ≥ 20%; or fulfillment of any of the previous three criteria.
• Data on interview responses, medication use, clinical examinations, laboratory results, and diabetes diagnoses were obtained from the participants.

TAKEAWAY:

• This study found that 3.6 million individuals (14.2%) were deemed highly likely to qualify for semaglutide treatment for the first time, and broadening the criteria for established CVD could increase this number to 15.2 million individuals (60.9%).
• If all newly eligible beneficiaries were to receive semaglutide treatment, Medicare spending could increase by $34-$145 billion annually.
• Even with more conservative definitions of CVD and a significant portion of individuals not maintaining long-term adherence to semaglutide treatment, costs could still increase by $10 billion annually.
• Younger, generally healthier, female Medicare beneficiaries were still likely to remain ineligible for semaglutide treatment according to the coverage provided by Part D Medicare plans.

IN PRACTICE:

“Although approximately one in seven Medicare beneficiaries with elevated BMI is likely to be newly eligible for semaglutide, the majority will remain ineligible if a narrow definition of established CVD is used by Part D plans. Weight control has benefits for patients with elevated BMI, so the definition of established CVD used by Part D plans for coverage of semaglutide could have outsized public health implications,” the authors wrote.

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women’s Hospital, Boston. It was published online in Annals of Internal Medicine.

LIMITATIONS: 

This analysis relied on self-reported cases of CVD. The study was also limited to only community-dwelling adults. It estimated maximum budgetary impacts but did not account for payment reforms introduced by the Inflation Reduction Act or for absolute contraindications to semaglutide.

DISCLOSURES:

This study did not disclose any sources of funding. Some authors declared receiving grants, serving as consultants, and having other ties with some institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Around one in seven Medicare beneficiaries with a high body mass index (BMI) may be newly eligible for semaglutide treatment after Medicare allowed Part D plans to cover the drug for patients with a BMI ≥ 27 and a history of cardiovascular disease (CVD), regardless of their diabetes status.

METHODOLOGY:

• In March 2024, Medicare approved the coverage of semaglutide by Part D plans for patients with a high BMI and existing CVD, irrespective of their diabetes status. This decision follows the SELECT trial results, showing that semaglutide lowered the risk for cardiovascular events in some patients without diabetes.
• This study aimed to describe the Medicare beneficiaries most likely to be newly eligible for semaglutide treatment and estimated maximum costs to Medicare Part D.
• The researchers included 5111 individuals aged ≥ 65 years with self-reported Medicare enrollment in the National Health and Nutrition Examination Survey between 2011 and 2020, all of whom had a BMI ≥ 27 and were likely to benefit from semaglutide treatment.
• They evaluated the following potential definitions of established CVD that could be considered by the Part D plan: physician-provided diagnosis of myocardial infarction, stroke, coronary artery disease, or angina; a 10-year risk for atherosclerotic CVD between 7.5% and < 20.0%; a 10-year risk for atherosclerotic CVD of ≥ 20%; or fulfillment of any of the previous three criteria.
• Data on interview responses, medication use, clinical examinations, laboratory results, and diabetes diagnoses were obtained from the participants.

TAKEAWAY:

• This study found that 3.6 million individuals (14.2%) were deemed highly likely to qualify for semaglutide treatment for the first time, and broadening the criteria for established CVD could increase this number to 15.2 million individuals (60.9%).
• If all newly eligible beneficiaries were to receive semaglutide treatment, Medicare spending could increase by $34-$145 billion annually.
• Even with more conservative definitions of CVD and a significant portion of individuals not maintaining long-term adherence to semaglutide treatment, costs could still increase by $10 billion annually.
• Younger, generally healthier, female Medicare beneficiaries were still likely to remain ineligible for semaglutide treatment according to the coverage provided by Part D Medicare plans.

IN PRACTICE:

“Although approximately one in seven Medicare beneficiaries with elevated BMI is likely to be newly eligible for semaglutide, the majority will remain ineligible if a narrow definition of established CVD is used by Part D plans. Weight control has benefits for patients with elevated BMI, so the definition of established CVD used by Part D plans for coverage of semaglutide could have outsized public health implications,” the authors wrote.

SOURCE:

The study was led by Alexander Chaitoff, MD, MPH, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women’s Hospital, Boston. It was published online in Annals of Internal Medicine.

LIMITATIONS: 

This analysis relied on self-reported cases of CVD. The study was also limited to only community-dwelling adults. It estimated maximum budgetary impacts but did not account for payment reforms introduced by the Inflation Reduction Act or for absolute contraindications to semaglutide.

DISCLOSURES:

This study did not disclose any sources of funding. Some authors declared receiving grants, serving as consultants, and having other ties with some institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.